The goal of this study is to evaluate the efficacy of autologous dentin graft (ADG) in treating periodontal defects on the distal aspect of mandibular 2nd molar (M2) after surgical removal of impacted mandibular 3rd molar (M3) by improving periodontal and radiological outcomes when compared with a xenograft, which is commercially available. The main questions it aims to answer are: 1. How does the clinical efficacy of ADG compare to xenografts, regarding wound healing and periodontal parameters at the distal aspect of periodontally compromised mandibular M2 following impacted M3 extraction? 2. How does the radiological bone regeneration at ADG-grafted sites differ from that at xenograft-grafted sites? 3. How do the post-operative patient-reported outcomes at sites receiving ADG differ from those at sites receiving xenografts? Researchers will compare ADG to xenograft to see if ADG is more efficacious in managing periodontal defects on distal aspect of M2 after surgical removal of M3. Participants will 1. Undergo bilateral surgical removal of M3 under general anaesthesia 2. Receive ADG on test site and xenograft on contralateral control site 3. Come back for clinical assessments, wound healing assessments and radiographic assessments for 5 times after the surgery (2 weeks, 1 month, 3 months, 6 months and 12 months)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Extracted mandibular M3 will be mechanically processed intraoperatively into dentine particles using the BonMaker® device (Korea Dental Solutions Co. Ltd., South Korea), in accordance with the manufacturer's instructions for chairside preparation of ADG.
Commercially available xenograft, which is of bovine derivative
Kuala Lumpur Hospital
Kuala Lumpur, Kuala Lumpur, Malaysia
Clinical Assessment
Probing pocket depth (PPD) (mm)
Time frame: Baseline, 3 months, 6 months, 12 months
Clinical Assessment
Clinical attachment level (CAL) (mm)
Time frame: Baseline, 3 months, 6 months, 12 months
Radiographic Assessment
Osseous defect depth (ODD)
Time frame: Baseline, 6 months, 12 months
Wound Healing Assessment
Landry Wound Healing Index
Time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months and 12 months
Patient Reported Outcome Measures
Visual Analogue Scales (VAS) will be used to capture post-operative pain. 100 mm VAS ruler will be used, where the scale is from 0 (no pain) to 100 (worst pain imaginable).
Time frame: Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month
Patient Reported Outcome Measures
Pain Intensity Score from the Malay validated version of the Brief Pain Inventory (BPI) questionnaire will be used. This section consists of 4 questions where the scale is from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month
Patient Reported Outcome Measures
Pain Interference Score from the Malay validated version of the Brief Pain Inventory (BPI) questionnaire will be used. This section consists of 7 questions where the scale is from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month
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